Clinical Study of Vitamin B5 in Adjuvant Treatment of IBD

NCT05701501 | Unknown DMC

• 1 other identifier: VitB5
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with IBD are randomized to oral administration of vitamin B5 and placebo based on the standard treatment, exploring whether Vitamin B5 can increase the clinical remission rate of IBD patients and improve the treatment effect.

Conditions

Inflammatory Bowel Diseases

Keywords

Vitamin B5,treatment

Outcome Measures

Primary Outcomes (1)

• Clinical remission rate

  To evaluate the improvement effect of clinical remission rate (Mayo score ≤ 2 points and no single sub-score\>1 point; CDAI score\<150) in IBD patients after 12 weeks of oral Vitamin B5 while taking routine treatment.

  Through study completion, an average of 12 months.

Secondary Outcomes (3)

• Disease activity score of IBD patients

  Through study completion, an average of 12 months.

• Histological remission

  Through study completion, an average of 12 months.

• Clinical response

  Through study completion, an average of 12 months.

Study Arms (2)

Vitamin B5 group

EXPERIMENTAL

Based on the standard IBD treatment, Vitamin B5 (5mg/tablet) is given orally three times a day, four tablets each time, for 12 weeks.

Drug: Vitamin B5 Tablets

Control group

PLACEBO COMPARATOR

Based on the standard IBD treatment, the same type of placebo tablets are given orally three times a day, four tablets each time, for 12 weeks.

Drug: placebo

Interventions

Vitamin B5 Tablets DRUG

The experimental group was given Vitamin tablets (5mg/tablet) based on the standard IBD treatment.

Vitamin B5 group

placebo DRUG

The control group was given placebo tablets of the same type based on the standard IBD treatment.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with IBD according to the consensus on the diagnosis and treatment of inflammatory bowel disease (Beijing, 2018, DOI:10.19538/j.nk2018090106);
• Have complete medical history data;
• Volunteer to participate in this clinical trial and sign the informed consent form.

You may not qualify if:

• Hemophilic patients;
• There are abdominal abscesses, toxic megacolon, fulminant colitis, partial colectomy, or total colectomy;
• Other autoimmune diseases, hematological diseases, tumors, acute infection, severe liver and kidney insufficiency, serious diseases such as severe anemia, neutropenia, heart failure, organic heart disease, hepatitis B, liver cirrhosis, kidney disease and mental diseases;
• Take calcium pantothenate preparation in recent 3 months;
• Have a history of abuse of psychoactive substances;
• Pregnant or lactating women, or plan to be pregnant in the next 6 months;
• Nervous system diseases: such as Alzheimer's disease, stroke, Parkinson's disease;
• Participate in other clinical trials in the past 6 months;
• Incomplete medical record information (including gender, age, diagnosis information, colonoscopy results, pathological diagnosis results and other demographic data)

Sponsors & Collaborators

• Changhai Hospital: lead
• The University of Science and Technology of China: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Pantothenic Acid

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Imides; Organic Chemicals; beta-Alanine; Alanine; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Zhaoshen Li, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

• Shu Zhu, PhD

  The University of Science and Technology of China

  STUDY DIRECTOR

Central Study Contacts

Zhaoshen Li, PhD, MD

CONTACT

+86-21-25070552; zhaoshenlismmu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of gastroenterology department

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)